Variation in Outcome Measures in Hip and Knee Arthroplasty Clinical Trials: A Proposed Approach to Achieving Consensus

Stanford University, Palo Alto, California, United States
The Journal of Rheumatology (Impact Factor: 3.19). 10/2009; 36(9):2050-6. DOI: 10.3899/jrheum090356
Source: PubMed


OMERACT began work over a decade ago on a consensus effort to identify optimal outcome measures for knee and hip osteoarthritis clinical trials. Recent evidence indicates extensive variation in outcome measures used in clinical trials of knee and hip arthroplasty published since 2000. This heterogeneity leads to confusion, not only for conducting systematic reviews but also for applying evidence to clinical practice. Given the extensive psychometric research conducted in the past 2 decades, the timing seems ideal to design and implement a study to develop consensus on optimal outcome measures for hip and knee arthroplasty trials. We describe a Delphi survey design and an approach for synthesizing the extensive psychometric literature on the outcome measures used in hip and knee arthroplasty trials. Plans for dissemination of the findings are also discussed. This proposed study could have an important influence on the design and reporting of future randomized trials of knee arthroplasty.

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Available from: Jasvinder A Singh, Sep 20, 2015
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    • "Mayo hip score was also associated with the risk of revision surgery at 2-years, both when examined as the final score and as a change score. These psychometric properties compared well to the HHS[5,192021, which at present is the most commonly used outcome instrument for THA outcome as- sessment[3,4]. An advantage of the Mayo hip score is[6]the hip implant that either physicians or patients can complete it, as compared to the HHS that has physician and patient portions. "
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    ABSTRACT: Background Previous studies have provided the initial evidence for construct validity and test-retest reliability of the Mayo Hip Score. Instruments used for Total Hip Arthroplasty (THA) outcomes assessment should be valid, reliable and responsive to change. Our main objective was to examine the responsiveness to change, association with subsequent revision and the construct validity of the Mayo hip score. Methods Discriminant ability was assessed by calculating effect size (ES), standardized response mean (SRM) and Guyatt’s responsiveness index (GRI). Minimal clinically important difference (MCII) and moderate improvement thresholds were calculated. We assessed construct validity by examining association of scores with preoperative patient characteristics and correlation with Harris hip score, and assessed association of scores with the risk of subsequent revision. Results Five thousand three hundred seven provided baseline data; of those with baseline data, 2,278 and 2,089 (39 %) provided 2- and 5-year data, respectively. Large ES, SRM and GRI ranging 2.66–2.78, 2.42–2.61 and 1.67–1.88 were noted for Mayo hip scores with THA, respectively. The MCII and moderate improvement thresholds were 22.4–22.7 and 39.4–40.5 respectively. Hazard ratios of revision surgery were higher with lower final score or less improvement in Mayo hip score at 2-years and borderline significant/non-significant at 5-years, respectively: (1) score ≤55 with hazard ratios of 2.24 (95 % CI, 1.45, 3.46; p = 0.0003) and 1.70 (95 % CI, 1.00, 2.92; p = 0.05) of implant revision subsequently, compared to 72-80 points; (2) no improvement or worsening score with hazard ratios 3.94 (95 % CI, 1.50, 10.30; p = 0.005) and 2.72 (95 % CI, 0.85,8.70; p = 0.09), compared to improvement >50-points. Mayo hip score had significant positive correlation with younger age, male gender, lower BMI, lower ASA class and lower Deyo-Charlson index (p ≤ 0.003 for each) and with Harris hip scores (p < 0.001). Conclusions Mayo Hip Score is valid, sensitive to change and associated with future risk of revision surgery in patients with primary THA.
    Preview · Article · Dec 2016 · BMC Musculoskeletal Disorders
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    • "A detailed discussion of issues related to MCID assessment and other aspects of HRQoL assessments in patients with arthroplasty with a focus on problems and solutions has been recently published [13]. An approach to achieving consensus in outcome assessments in patients with arthroplasty is needed and was discussed by Riddle and colleagues in a recent publication [14]. "
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    ABSTRACT: Responsiveness to change is an important psychometric property of an outcome instrument. Assessment of health-related quality of life (HRQoL) is critical to outcome assessment after total joint replacement, a surgery aimed at improving pain, function and HRQoL of the patients undergoing these procedures. In a recent study, Shi et al. examined the responsiveness to change of various subscales of two instruments, physician-administered Harris Hip Score and patient self-administered Short Form-36 (SF-36), 6 months after revision total hip arthroplasty. The responsiveness statistics for both scales were reasonable, higher for Harris Hip Score than SF-36. This is the first study to examine responsiveness of these instruments in revision THA patients in a systematic fashion.
    Full-text · Article · May 2011 · BMC Musculoskeletal Disorders
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    ABSTRACT: BLDSC reference no.: D225150. Supervisor: Jenny Green. Thesis (D. Phil.)--University of Oxford, 2003. Includes bibliographical references.
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